Catalog Number

RTBS

Brand Name

Tuohy Borst Simple

Version/Model Number

ROMTB-ST245

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

Labeling does not contain MRI Safety Information

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

Yes

For Single-Use

Yes

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code

GBX

Product Code Name

Catheter, Irrigation

Public Device Record Key

54fde0b1-4c5c-4ced-9054-4d8529774766

Public Version Date

March 04, 2021

Public Version Number

1

DI Record Publish Date

February 24, 2021

Package DI Number

03700512978220

Quantity per Package

10

Contains DI Package

03700512968221

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box 1